Page 4 Effect of telehealth on quality of life and psychological out comes over 12 months
P. 4
BMJ 2013;346:f653 doi: 10.1136/bmj.f653 (Published 26 February 2013) Page 4 of 20
RESEARCH
were contacted to arrange a home visit to discuss the research provided, transfer of data to the monitoring centres, triage or
in more detail. At this visit, the suitability of the participant’s risk stratification, and response pathways reflected variations
home infrastructure was checked, and a participant information that would occur if telehealth was implemented across the UK’s
sheet and consent form were provided. Participants provided entire health system.
written consent and indicated whether they would be willing to
take part in the supplementary questionnaire study. Those Usual care treatment (control arm)
willing were contacted by trained interviewers to arrange a Participants allocated to the control arm continued to receive
baseline interview in the participant’s home. At baseline their existing healthcare and social services, in line with local
interview, patients received a second information sheet relating protocols, for the 12 months of the trial. Across the three WSD
specifically to the questionnaire study, and signed a second sites, healthcare was provided by a combination of community
consent form for this part of the evaluation. matrons, district nurses, specialist nurses, general practitioners,
To minimise participant burden and create mutually exclusive and hospital services based on clinical need. Patients had
subgroups for subsequent disease specific analyses (not reported pre-established, tailored care plans that included routine
here), participants with at least two of the three long term assessments at a frequency appropriate for their disease
conditions were allocated to a single index condition using severity—typically ranging from once per week to once or twice
simple randomisation. Based on a prospective power calculation per year. Control participants had no telehealth or telecare
(see below), we aimed to recruit 1650 participants into the equipment installed their homes for the duration of the study.
questionnaire study with an approximately even split between A Lifeline pendant (a personal alarm) plus a smoke alarm linked
the three long term conditions (fig 2⇓). Recruitment ended in to a monitoring centre were not, on their own, sufficient to
December 2009. classify as telecare for current purposes. We planned to reassess
control participants at the end of the trial and, if still eligible,
Telehealth treatment (intervention arm) offer them telehealth.
To facilitate comparisons between clinical studies, four classes All participants (intervention and control) were beneficiaries of
(or “generations”) of telehealth have recently been proposed on the Whole Systems Redesign, which was a precondition of sites’
the basis of the type of data transfer, decision making ability of participation in the trial. Putative benefits for patients included
the care provider reviewing the data, and level of integration of a better understanding of their condition and how to look after
all systems with the patient’s primary care structure. 40 themselves through the development of self care behaviours
First generation telehealth comprises non-reactive data collection and the continued support of services such as community
and analysis systems. Measurements of interest are collected matrons (web appendix 1).
and transferred to the care provider asynchronously (that is, by
store and forward protocols). There is no full telemedical system, Trial assessment procedures
and the provider cannot respond immediately to patient data. Outcomes were assessed at the level of the patient. At baseline,
Second generation systems have a non-immediate analytical or questions on outcome measures were answered by participants
decision making structure. Data transfer is synchronous—that with a trained researcher on hand to explain or clarify the
is, there is some real time processing of patient data using, for meaning of particular questions or assist with completing the
example, automated algorithms to interpret the data. Care questionnaire if participants were physically unable to do so.
providers can recognise important changes in essential After the baseline interview, two further assessments were
measurements, but delays can occur if the systems are only conducted. A short term assessment was conducted at about
active during office hours. four months (median duration 127 days (interquartile range 37);
Third generation systems provide constant analytical and 132 days (40) for control group, 126 days (35) for intervention
decision making support. Monitoring centres are physician led, group), and a long term assessment at around 12 months (347
staffed by specialist nurses, and have full therapeutic authority days (49); 358 days (48), 342 days (47)). Duration at both
24 h per day, seven days per week. Fourth generation systems assessments was similar across trial arms.
are an extension of third generation systems, comprising The questionnaire battery was the same at baseline and at short
invasive (such as with surgical implantation) and non-invasive term; long term assessment included two additional scales
telemedical devices for data collection. The complexity of measuring functional status and impact of illness (not reported
56
57
incoming information and subsequent therapeutic decisions here). At short term assessment, the survey battery was primarily
requires the continuous presence of a physician. administered as a postal survey with one reminder letter for
WSD sites delivered variations of telehealth, but all systems non-responders; some participants also received telephone
focused on monitoring vital signs, symptoms, and self reminders. At long term assessment, the survey was posted to
management behaviour. They provided general and disease participants and non-responders were contacted to arrange a
specific health education, with non-immediate review by home interview with a trained researcher, in line with the
specialist nurses and other care providers. This configuration baseline protocol. Participants who did not complete a
most closely approximates second generation telehealth. questionnaire at short term were still invited to complete a
Web appendix 2 and figure 3⇓ describe the WSD telehealth questionnaire at long term. However, participants who withdrew
intervention. Web figure 1 shows the provision of peripheral from the trial, including intervention participants who asked for
telehealth devices to intervention participants according to the telehealth equipment to be removed before the end of the
diagnosis of long term condition in each WSD site. Sites differed 12 month trial period, were not sent further questionnaires after
in the number of peripheral devices installed per participant, their withdrawal date.
with a mode (across all long term conditions) of two in Cornwall
and three in Kent and Newham. Web figure 2 shows the early Patient reported outcomes
removal of telehealth from participants for reasons other than Findings in the current report are based on instruments assessing
death, by site. Differences in functionality of the telehealth different domains of generic health related QoL (SF-12, EQ-5D),
equipment supplied, type and number of peripheral devices anxiety (Brief State-Trait Anxiety Inventory (STAI)), and
No commercial reuse: See rights and reprints http://www.bmj.com/permissions Subscribe: http://www.bmj.com/subscribe
RESEARCH
were contacted to arrange a home visit to discuss the research provided, transfer of data to the monitoring centres, triage or
in more detail. At this visit, the suitability of the participant’s risk stratification, and response pathways reflected variations
home infrastructure was checked, and a participant information that would occur if telehealth was implemented across the UK’s
sheet and consent form were provided. Participants provided entire health system.
written consent and indicated whether they would be willing to
take part in the supplementary questionnaire study. Those Usual care treatment (control arm)
willing were contacted by trained interviewers to arrange a Participants allocated to the control arm continued to receive
baseline interview in the participant’s home. At baseline their existing healthcare and social services, in line with local
interview, patients received a second information sheet relating protocols, for the 12 months of the trial. Across the three WSD
specifically to the questionnaire study, and signed a second sites, healthcare was provided by a combination of community
consent form for this part of the evaluation. matrons, district nurses, specialist nurses, general practitioners,
To minimise participant burden and create mutually exclusive and hospital services based on clinical need. Patients had
subgroups for subsequent disease specific analyses (not reported pre-established, tailored care plans that included routine
here), participants with at least two of the three long term assessments at a frequency appropriate for their disease
conditions were allocated to a single index condition using severity—typically ranging from once per week to once or twice
simple randomisation. Based on a prospective power calculation per year. Control participants had no telehealth or telecare
(see below), we aimed to recruit 1650 participants into the equipment installed their homes for the duration of the study.
questionnaire study with an approximately even split between A Lifeline pendant (a personal alarm) plus a smoke alarm linked
the three long term conditions (fig 2⇓). Recruitment ended in to a monitoring centre were not, on their own, sufficient to
December 2009. classify as telecare for current purposes. We planned to reassess
control participants at the end of the trial and, if still eligible,
Telehealth treatment (intervention arm) offer them telehealth.
To facilitate comparisons between clinical studies, four classes All participants (intervention and control) were beneficiaries of
(or “generations”) of telehealth have recently been proposed on the Whole Systems Redesign, which was a precondition of sites’
the basis of the type of data transfer, decision making ability of participation in the trial. Putative benefits for patients included
the care provider reviewing the data, and level of integration of a better understanding of their condition and how to look after
all systems with the patient’s primary care structure. 40 themselves through the development of self care behaviours
First generation telehealth comprises non-reactive data collection and the continued support of services such as community
and analysis systems. Measurements of interest are collected matrons (web appendix 1).
and transferred to the care provider asynchronously (that is, by
store and forward protocols). There is no full telemedical system, Trial assessment procedures
and the provider cannot respond immediately to patient data. Outcomes were assessed at the level of the patient. At baseline,
Second generation systems have a non-immediate analytical or questions on outcome measures were answered by participants
decision making structure. Data transfer is synchronous—that with a trained researcher on hand to explain or clarify the
is, there is some real time processing of patient data using, for meaning of particular questions or assist with completing the
example, automated algorithms to interpret the data. Care questionnaire if participants were physically unable to do so.
providers can recognise important changes in essential After the baseline interview, two further assessments were
measurements, but delays can occur if the systems are only conducted. A short term assessment was conducted at about
active during office hours. four months (median duration 127 days (interquartile range 37);
Third generation systems provide constant analytical and 132 days (40) for control group, 126 days (35) for intervention
decision making support. Monitoring centres are physician led, group), and a long term assessment at around 12 months (347
staffed by specialist nurses, and have full therapeutic authority days (49); 358 days (48), 342 days (47)). Duration at both
24 h per day, seven days per week. Fourth generation systems assessments was similar across trial arms.
are an extension of third generation systems, comprising The questionnaire battery was the same at baseline and at short
invasive (such as with surgical implantation) and non-invasive term; long term assessment included two additional scales
telemedical devices for data collection. The complexity of measuring functional status and impact of illness (not reported
56
57
incoming information and subsequent therapeutic decisions here). At short term assessment, the survey battery was primarily
requires the continuous presence of a physician. administered as a postal survey with one reminder letter for
WSD sites delivered variations of telehealth, but all systems non-responders; some participants also received telephone
focused on monitoring vital signs, symptoms, and self reminders. At long term assessment, the survey was posted to
management behaviour. They provided general and disease participants and non-responders were contacted to arrange a
specific health education, with non-immediate review by home interview with a trained researcher, in line with the
specialist nurses and other care providers. This configuration baseline protocol. Participants who did not complete a
most closely approximates second generation telehealth. questionnaire at short term were still invited to complete a
Web appendix 2 and figure 3⇓ describe the WSD telehealth questionnaire at long term. However, participants who withdrew
intervention. Web figure 1 shows the provision of peripheral from the trial, including intervention participants who asked for
telehealth devices to intervention participants according to the telehealth equipment to be removed before the end of the
diagnosis of long term condition in each WSD site. Sites differed 12 month trial period, were not sent further questionnaires after
in the number of peripheral devices installed per participant, their withdrawal date.
with a mode (across all long term conditions) of two in Cornwall
and three in Kent and Newham. Web figure 2 shows the early Patient reported outcomes
removal of telehealth from participants for reasons other than Findings in the current report are based on instruments assessing
death, by site. Differences in functionality of the telehealth different domains of generic health related QoL (SF-12, EQ-5D),
equipment supplied, type and number of peripheral devices anxiety (Brief State-Trait Anxiety Inventory (STAI)), and
No commercial reuse: See rights and reprints http://www.bmj.com/permissions Subscribe: http://www.bmj.com/subscribe
